MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FMC BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 08/06/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.The post market surveillance department received medical records associated with the reported event.Both a clinical investigation and plant investigation are in process.A supplemental mdr will be submitted upon completion of these activities.

Event Description

The user facility medical records, which were provided for an unrelated event, stated that the patient experienced chest pain while undergoing a hemodialysis (hd) treatment on (b)(6) 2014.Reportedly, approximately 1 hour into the hd treatment, the patient began coughing.The cough was noted as being a chronic cough with expectorate of clear white sputum.The patient also experienced shortness of breath.At that time, the treatment was discontinued, and then the patient was transferred to the hospital.Upon arrival, the patient was admitted, and subsequently discharged home on (b)(6) 2014.No product malfunctions occurred, identified, or alleged during the pre-hospitalization hd treatment.No other event related information was made available.Follow-up information was provided which revealed that the patient resumed outpatient hemodialysis treatments following their discharge from the hospital.The 2008k hemodialysis machine is not available for evaluation.The dialyzer and bloodline are not available for evaluation by the manufacturer as both were discarded by the user facility.No samples of the acid/bicarb in use during the treatment are available for analysis.

Manufacturer Narrative

Manufacturing evaluation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodlines shipped to this account within the selected time frame.A records review was performed on all lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.Clinical investigation: the patient medical records were provided by the facility on march 6, 2016 and april 7, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.Medical records did not contain physician (md) or nurse (rn) progress notes, hemodialysis (hd) treatment orders, treatment sheets or medication administration record.There is no indication that a device malfunction occurred.No malfunction was reported, identified, or alleged.Based on the medical records received and customer contact information, there is no documentation that indicates a causal relationship between the hd treatment performed on (b)(6) 2014 and the chest pain experienced by the patient.

Event Description

The following event information was identified during a secondary review of the patient medical records.The patient¿s vital signs while in the emergency room (er) were noted as being: temperature 36.7, pulse 70, respiratory rate 18, blood pressure (bp) 160/81, oxygen saturation 99% on nasal cannula 4l.The patients¿ physical assessment including initial cardiac assessment was negative.In er, the physician stated the patient¿s ¿chest is tender to palpation suggesting costochondritis.¿.

• Brand Name: FMC BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5574181
• MDR Text Key: 42559998
• Report Number: 8030665-2016-00179
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 44